{"id":1124,"date":"2025-12-12T03:32:15","date_gmt":"2025-12-12T03:32:15","guid":{"rendered":"https:\/\/test.geo-tester.com\/?p=1124"},"modified":"2025-12-12T03:32:18","modified_gmt":"2025-12-12T03:32:18","slug":"medical-device-function-and-performance-testing","status":"publish","type":"post","link":"https:\/\/test.geo-tester.com\/ko\/resources\/medical-device-function-and-performance-testing.html","title":{"rendered":"\uc758\ub8cc \uae30\uae30 \uae30\ub2a5 \ubc0f \uc131\ub2a5 \ud14c\uc2a4\ud2b8"},"content":{"rendered":"

\uc758\ub8cc \uae30\uae30 \uae30\ub2a5 \ubc0f \uc131\ub2a5 \ud14c\uc2a4\ud2b8<\/h2>\n\n\n\n

\ub2e4\uc591\ud55c \uc758\ub8cc \uae30\uae30 \ubd84\uc57c\uc758 \uaddc\uc81c \uc694\uac74\uc744 \ucda9\uc871\ud558\ub824\uba74 \ub2a5\uc219\ud55c \ud504\ub85c\uc81d\ud2b8 \uad00\ub9ac\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. \uc774\ub294 \uc5b4\ub835\uace0 \ubcf5\uc7a1\ud55c \uc791\uc5c5\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc608\uc0b0 \ubc94\uc704 \ub0b4\uc5d0\uc11c \ucd09\ubc15\ud55c \ub9c8\uac10 \uae30\ud55c\uc744 \uc9c0\ud0a4\uba74\uc11c \ub2e4\uc591\ud55c \uc774\ud574\uad00\uacc4\uc790\uc758 \uc694\uad6c \uc0ac\ud56d \uc0ac\uc774\uc5d0\uc11c \uade0\ud615\uc744 \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4. \uae30\uae30\uc758 \uc784\uc0c1\uc801 \uc694\uad6c \uc0ac\ud56d\uacfc \uc548\uc804\uc131\uc774 \uac00\uc7a5 \uc911\uc694\ud558\uba70 \uc774\ub97c \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4.  <\/p>\n\n\n\n

\uc2e0\uc18d\ud558\uace0 \uacbd\uc7c1\ub825 \uc788\ub294 \uacac\uc801<\/p>\n\n\n\n

\uc2e0\uc18d\ud55c \ud504\ub85c\uc81d\ud2b8 \uc2dc\uc791<\/p>\n\n\n\n

\uc7a5\ube44\uc5d0 \ub300\ud55c \uc2e0\uc18d\ud55c \uc561\uc138\uc2a4<\/p>\n\n\n\n

\ud6a8\uc728\uc801\uc778 \uc804\ub2ec \ubc0f \ubcf4\uace0<\/p>\n\n\n\n

\uc800\ud76c\ub294 ISO 17025\uc640 GMP\ub97c \uc900\uc218\ud569\ub2c8\ub2e4. \uacc4\uc57d(\uad6c\ub9e4 \uc8fc\ubb38\uc11c, \uc791\uc5c5 \ub0b4\uc5ed\uc11c \ub610\ub294 \uae30\uc220 \uacc4\uc57d\uc11c)\uc774 \uccb4\uacb0\ub418\uba74 \uba70\uce60 \uc774\ub0b4\uc5d0 \uadc0\ud558\uc758 \uc2b9\uc778 \ub610\ub294 \uc758\uacac\uc5d0 \ub300\ud55c \ud504\ub85c\ud1a0\ucf5c\uc744 \ud68c\uc2e0\ud574 \ub4dc\ub9bd\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc758\ub8cc \uae30\uae30 \ud14c\uc2a4\ud2b8\ub294 \uae30\uae30\uac00 \uc0ac\uc6a9 \uc911 \uc548\uc815\uc801\uc774\uace0 \uc548\uc804\ud558\uac8c \uc791\ub3d9\ud55c\ub2e4\ub294 \uac83\uc744 \uc785\uc99d\ud558\ub294 \ud504\ub85c\uc138\uc2a4\uc785\ub2c8\ub2e4.. <\/strong>\uc2e0\uc81c\ud488 \uac1c\ubc1c\uc5d0\ub294 \uad11\ubc94\uc704\ud55c \uc124\uacc4 \uac80\uc99d \ud14c\uc2a4\ud2b8\uac00 \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uc131\ub2a5 \ud14c\uc2a4\ud2b8, \ub3c5\uc131 \ubc0f \ud654\ud559 \ubd84\uc11d, \ub54c\ub85c\ub294 \uc778\uc801 \uc694\uc778\uc774\ub098 \uc784\uc0c1 \ud14c\uc2a4\ud2b8\uae4c\uc9c0 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc9c0\uc18d\uc801\uc778 \ud488\uc9c8 \ubcf4\uc99d \ud14c\uc2a4\ud2b8\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ub354 \uc81c\ud55c\uc801\uc785\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uce58\uc218 \uac80\uc0ac, \uc77c\ubd80 \uae30\ub2a5 \ud14c\uc2a4\ud2b8 \ubc0f \ud3ec\uc7a5 \uac80\uc99d\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc131\ub2a5 \ud14c\uc2a4\ud2b8<\/p>\n\n\n\n

\uc800\ud76c \uc2e4\ud5d8\uc2e4\uc740 \ud45c\uba74 \uc811\ucd09\uc5d0\uc11c \uc601\uad6c \uc784\ud50c\ub780\ud2b8\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0 \ub2e4\uc591\ud55c \uc758\ub8cc \uae30\uae30\ub294 \ubb3c\ub860 \uc790\ub3d9 \uc8fc\uc785\uae30\uc5d0\uc11c \uc2a4\ud504\ub808\uc774 \ubc0f \ud06c\ub9bc\uc5d0 \uc774\ub974\ub294 \uc57d\ubb3c \uc804\ub2ec \uc81c\ud488\uc5d0 \ub300\ud55c \ubc29\ub300\ud55c \uacbd\ud5d8\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc2e4\ud5d8\uc2e4 \ud14c\uc2a4\ud2b8- \uc790\uc138\ud788 \ubcf4\uae30...<\/p>\n\n\n\n

\uc7ac\ub8cc \ud14c\uc2a4\ud2b8<\/p>\n\n\n\n

\uc7ac\ub8cc \ud2b9\uc131\ud654\ub294 \uc758\ub8cc \uae30\uae30 \uac1c\ubc1c \ubc0f \uc0dd\uc0b0\uc5d0 \ub9ce\uc740 \uc751\uc6a9 \ubd84\uc57c\ub97c \uac00\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub294 \u2019\uc9c0\ubb38'\uc744 \uc2dd\ubcc4\ud558\uae30 \uc704\ud55c \uc7ac\ub8cc\uc758 \ud654\ud559\uc801 \ubd84\uc11d\uc785\ub2c8\ub2e4. \uc774 \uc815\ubcf4\ub294 \uc0dd\uc0b0 \ubc0f \uc124\uacc4 \ubcc0\uacbd\ubfd0\ub9cc \uc544\ub2c8\ub77c \uc0c8\ub85c\uc6b4 \uc124\uacc4\uc758 \ub3c5\uc131 \uc2dc\ud5d8\uc744 \ucd5c\uc18c\ud654\ud558\ub294 \ub370 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \ud654\ud559\uc801 \uc2dd\ubcc4\uc740 \uc785\uace0\ub418\ub294 \uc6d0\uc790\uc7ac\uc640 \ub85c\ud2b8 \uac04 \uc0dd\uc0b0\uc5d0\ub3c4 \uc801\uc6a9\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.  <\/p>\n\n\n\n

\uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8<\/p>\n\n\n\n

\uc758\ub8cc \uae30\uae30\ub294 \ubd84\ub958\uc5d0 \ub530\ub77c \ub2e4\uc591\ud55c \uc218\uc900\uc758 \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. \uc0dd\ubb3c\ud559\uc801 \uc548\uc804\uc5d0 \ub300\ud55c \ud544\uc218 \uc694\uac74\uc5d0 \ub300\ud55c \uc8fc\uc694 \uc9c0\uce68\uc740 ISO 10993 - \uc758\ub8cc \uae30\uae30\uc758 \uc0dd\ubb3c\ud559\uc801 \ud3c9\uac00\uc785\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uce68\uc2b5\uc131 \ubc0f \ud658\uc790 \uc811\ucd09 \uae30\uac04\uc5d0 \ub530\ub77c \uae30\uae30\ub97c \uc815\uc758\ud558\uace0, \uc774\ud6c4 \uc81c\uc870\uc5c5\uccb4\uac00 \uae30\uae30\ub97c \uc2dc\uc7a5\uc5d0 \ucd9c\uc2dc\ud558\uae30 \uc804\uc5d0 \uc131\uacf5\uc801\uc73c\ub85c \uc644\ub8cc\ud574\uc57c \ud558\ub294 \uc548\uc804 \ud14c\uc2a4\ud2b8 \uc218\uc900\uc744 \uacb0\uc815\ud569\ub2c8\ub2e4. \uc548\uc804 \ud14c\uc2a4\ud2b8- \uc790\uc138\ud788 \ubcf4\uae30...<\/p>\n\n\n\n

\ud37c\uc2a4\ud2b8 \ub77c\uc778 QA<\/p>\n\n\n\n

\uc81c\ud488 \ubd88\ub9cc\uc73c\ub85c \uc778\ud574 \uc778\ub825\uc774 \ub2e4\ub978 \uacf3\uc5d0 \uc4f8 \uc218 \uc788\ub294 \ub9ac\uc18c\uc2a4\ub97c \ub0ad\ube44\ud558\uace0 \uc788\uc9c0\ub294 \uc54a\ub098\uc694? \uace0\uac1d \ubc18\ud488\uc740 \ube44\uc988\ub2c8\uc2a4\uc5d0\uc11c \ud53c\ud560 \uc218 \uc5c6\ub294 \ubd80\ubd84\uc774\uc9c0\ub9cc, \ubc18\ub4dc\uc2dc \uadc0\uc0ac\uc758 \ud544\uc218\uc801\uc778 \ubd80\ubd84\uc77c \ud544\uc694\ub294 \uc5c6\uc2b5\ub2c8\ub2e4! \ub2f9\uc0ac\uc758 \uace0\uc720\ud55c \ud37c\uc2a4\ud2b8 \ub77c\uc778 QA \uc11c\ube44\uc2a4\ub97c \uc0ac\uc6a9\ud558\uba74 \u201c\uc720\ub7fd \uc2dc\uc7a5\uc5d0\uc11c \ud310\ub9e4\ud558\ub294 \ubaa8\ub4e0 \uc81c\uc870\uc5c5\uccb4\ub294 \uacbd\uacc4\ub97c \ud655\uc2e4\ud788 \ud574\uc57c \ud55c\ub2e4\u201d\uace0 \uaddc\uc815\ud558\ub294 EU MEDDEV 2.12-1 Rev 5 \u201c\uc758\ub8cc \uae30\uae30 \uacbd\uacc4 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc9c0\uce68\"\uc744 \uc27d\uac8c \uc900\uc218\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ubd88\ub9cc \uc0ac\ud56d \ubd84\uc11d- \uc790\uc138\ud788 \ubcf4\uae30...<\/p>\n\n\n\n

\uc758\ub8cc \uae30\uae30 \ud14c\uc2a4\ud2b8<\/h2>\n\n\n\n

2021\ub144 5\uc6d4 26\uc77c, \uc758\ub8cc\uae30\uae30 \uc9c0\uce68(MDD)\uc774 \uc0c8\ub85c\uc6b4 \uc758\ub8cc\uae30\uae30 \uaddc\uc815(MDR)\uc73c\ub85c \ub300\uccb4\ub418\uc5c8\uc2b5\ub2c8\ub2e4. MDR\uc740 MDD\uc758 \uac1c\uc120\ub41c \ubc84\uc804\uc73c\ub85c, \uc8fc\uc694 \ucc28\uc774\uc810\uc740 \uaddc\uc815\uc73c\ub85c\uc11c \ubaa8\ub4e0 EU \ud68c\uc6d0\uad6d\uc5d0\uc11c \uc9c1\uc811 \uc2dc\ud589\ud574\uc57c \ud55c\ub2e4\ub294 \uac83\uc785\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 MDR\uc740 \ubaa8\ub4e0 \ud68c\uc6d0\uad6d\uc744 \uc704\ud55c \ud1b5\uc77c\ub418\uace0 \uacf5\uc815\ud55c \uaddc\uc815\uc744 \ub9cc\ub4e4\uace0 \ud488\uc9c8 \ubc0f \uc548\uc804 \uc870\uce58\uc5d0 \ub300\ud55c \uae30\uc900\uc744 \ub192\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

MDR\uc740 \ubaa8\ub4e0 EU \ud68c\uc6d0\uad6d\uc73c\ub85c \ud655\ub300 \uc801\uc6a9\ub420 \ubfd0\ub9cc \uc544\ub2c8\ub77c, \uc81c\uacf5\ub418\ub294 \uc9c0\uce68\uc744 \ud1b5\ud574 \uae30\uc5c5\ub4e4\uc774 \ud604\uc7ac\uc758 \uc81c\ud488 \uc704\uc0dd\uacfc \uc548\uc804\uc744 \uac1c\uc120\ud558\uace0 \ud589\ub3d9\ud558\ub3c4\ub85d \uc7a5\ub824\ud558\uc5ec \uc804\ubc18\uc801\uc778 \uae30\uc900\uc744 \ud06c\uac8c \ud5a5\uc0c1\uc2dc\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774 \uaddc\uc815\uc758 \uc870\ud56d\uc5d0 \ub530\ub77c \uae30\uc5c5\uc740 \ud3ec\ud2b8\ud3f4\ub9ac\uc624\ub97c \uac80\ud1a0\ud558\uace0 \uaddc\uc815\uc744 \uc900\uc218\ud558\uae30 \uc704\ud574 \ud544\uc694\ud55c \ubcc0\uacbd\uc744 \ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc758\ub8cc \uae30\uae30\uc5d0\ub294 \uc0ac\uc6a9\uc790, \ud658\uc790 \ubc0f \uc81c3\uc790\uc758 \uac74\uac15\uc744 \ubcf4\ud638\ud558\uae30 \uc704\ud55c \uba87 \uac00\uc9c0 \uaddc\uc81c \uc694\uac74\uc774 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\uac00\uc7a5 \uc911\uc694\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc5ec\uae30\uc5d0 \ub098\uc5f4\ud588\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n

DIN EN ISO 14155\uc5d0 \ub530\ub978 \uc804\uc6a9 \ud14c\uc2a4\ud2b8 \uacc4\ud68d \uc99d\uba85<\/p>\n\n\n\n

\ud574\ub2f9 \uc81c\ud488\uc758 \uc548\uc804\uc131\uc744 \uc99d\uba85\ud558\ub294 \uc790\ub8cc<\/p>\n\n\n\n

\uad00\ud560 \uc5f0\ubc29 \uc0c1\uae09 \uae30\uad00 BfArM\uc758 \uc2b9\uc778(\u00a7 22a MPG)<\/p>\n\n\n\n

\uc724\ub9ac \uc704\uc6d0\ud68c \uc2b9\uc778<\/p>\n\n\n\n

\ud658\uc790 \uc815\ubcf4 \ubc0f \ub3d9\uc758<\/p>\n\n\n\n

\ud504\ub85c\ubc34\ub4dc \ubcf4\ud5d8 \uccb4\uacb0<\/p>\n\n\n\n

\ubbf8\uad6d\uc5d0\uc11c\ub294 FDA\uc758 \uc758\ub8cc\uae30\uae30 \ubc0f \ubc29\uc0ac\uc120 \ubcf4\uac74 \uc13c\ud130(CDRH)\uac00 \ubbf8\uad6d\uc5d0\uc11c \uc81c\uc870 \ubc0f \ud310\ub9e4\ub418\ub294 \uc758\ub8cc \uae30\uae30\ub97c \uaddc\uc81c\ud558\ub294 \uc5c5\ubb34\ub97c \ub2f4\ub2f9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\ubbf8\uad6d\uc758 \uc758\ub8cc \uae30\uae30\ub294 \ub4f1\uae09(I, II, III)\uc5d0 \ub530\ub77c \uc815\uc758\ub429\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ub4f1\uae09\uc5d0 \ub530\ub77c \ud574\ub2f9 \uae30\uae30 \ub610\ub294 \uae30\uc220\uc774 \uc900\uc218\ud574\uc57c \ud558\ub294 \uaddc\uc81c \uc694\uac74\uc774 \uacb0\uc815\ub429\ub2c8\ub2e4. \ubaa8\ub4e0 \uc81c\uc870\uc5c5\uccb4\uc640 \uc720\ud1b5\uc5c5\uccb4\ub294 10\uc6d4 1\uc77c\ubd80\ud130 12\uc6d4 31\uc77c \uc0ac\uc774\uc5d0 FDA\uc5d0 \ub4f1\ub85d\ud574\uc57c \ud569\ub2c8\ub2e4. \uc758\ub8cc \uae30\uae30\ub97c \ub4f1\ub85d\ud560 \ub54c\ub294 \ud3ec\uc7a5\uc5c5\uccb4, \uc81c\uc870\uc5c5\uccb4, \ub77c\ubca8 \uc81c\uc791\uc5c5\uccb4, \uac1c\ubc1c\uc790, \uba78\uade0\uc5c5\uccb4 \ub4f1 \uc81c\ud488 \uc81c\uc791\uc5d0 \uad00\uc5ec\ud55c \ubaa8\ub4e0 \uc5c5\uccb4\ub97c \uae30\uc7ac\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc758\ub8cc \uae30\uae30\uc758 \ub4f1\uae09\uc5d0 \ub530\ub77c PMA \uac80\ud1a0 \ubc0f \uc81c3\uc790 \uac80\ud1a0\uc640 \uac19\uc740 \uae30\ud0c0 \uaddc\uc815\uacfc \ud568\uaed8 \uc2dc\ud310 \uc804 \uc2e0\uace0\uc11c\ub97c \uc81c\ucd9c\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\ubbf8\uad6d\uc5d0\uc11c\ub294 \uc758\ub8cc \uae30\uae30\uac00 \uc0ac\ub78c\uc758 \ubd80\uc0c1\uc774\ub098 \uc0ac\ub9dd\uc744 \ucd08\ub798\ud558\uac70\ub098 \uc774\uc5d0 \uae30\uc5ec\ud55c \ubaa8\ub4e0 \uc0ac\uac74\uc744 FDA\uc5d0 \ubcf4\uace0\ud574\uc57c \ud569\ub2c8\ub2e4. \ubaa8\ub4e0 \uc624\uc791\ub3d9\uc740 \ubc18\ub4dc\uc2dc \ubcf4\uace0\ud558\uc5ec \uc218\uc815\ud560 \uc218 \uc788\ub3c4\ub85d \ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud14c\uc2a4\ud2b8\uc5d0 \ub300\ud55c \uc644\ubcbd\ud55c \uac00\uc774\ub4dc<\/h2>\n\n\n\n

 <\/h3>\n\n\n\n

\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc5d0\ub294 \uc758\ub8cc \uae30\uae30\uc6a9 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud14c\uc2a4\ud2b8\uc640 \uad00\ub828\ub41c \uc5ec\ub7ec \uaddc\uc815\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uaddc\uc815\uc740 \uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc548\uc804\uc131, \ud6a8\uacfc\uc131, \uc2e0\ub8b0\uc131\uc744 \ubcf4\uc7a5\ud558\uba70, \uadf8 \uacb0\uacfc\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ud574\ub2f9 \uae30\uad00\uc5d0 \uc81c\ucd9c\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc911\uc694\ud55c \uaddc\uc815 \uc911 \ud558\ub098\ub294 \uc758\ub8cc \uae30\uae30\uc5d0 \ud3ec\ud568\ub41c \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc2dc\ud310 \uc804 \uc81c\ucd9c \ub0b4\uc6a9\uc5d0 \ub300\ud55c FDA\uc758 \uc9c0\uce68\uc785\ub2c8\ub2e4. \uc774 \uc9c0\uce68\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc758\ub3c4\ub41c \uc0ac\uc6a9, \uae30\uae30 \uc704\ud5d8 \ubd84\uc11d \ubc0f \ud14c\uc2a4\ud2b8 \ud504\ub85c\ud1a0\ucf5c\uc5d0 \ub300\ud55c \uc138\ubd80 \uc815\ubcf4\ub97c \ud3ec\ud568\ud558\uc5ec \uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc2dc\ud310 \uc804 \uc81c\ucd9c\uc5d0 \ud3ec\ud568\ub418\uc5b4\uc57c \ud558\ub294 \uc815\ubcf4\ub97c \uac04\ub7b5\ud558\uac8c \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\ub610 \ub2e4\ub978 \uc8fc\uc694 \uaddc\uc815\uc73c\ub85c\ub294 \uc758\ub8cc \uae30\uae30\uc5d0\uc11c \uc0ac\uc6a9\ud558\uae30 \uc704\ud55c \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac80\uc99d\uc5d0 \ub300\ud55c \uc9c0\uce68\uc744 \uc81c\uacf5\ud558\ub294 FDA\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac80\uc99d \uc77c\ubc18 \uc6d0\uce59\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \uaddc\uc815\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c \uc218\uba85 \uc8fc\uae30, \ubb38\uc11c\ud654 \ubc0f \ud14c\uc2a4\ud2b8 \ubc29\ubc95\uacfc \uac19\uc740 \uc8fc\uc81c\ub97c \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774\ub7ec\ud55c \uaddc\uc815 \uc678\uc5d0\ub3c4 FDA\ub294 \uae30\uc874 \uc758\ub8cc \uae30\uae30\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ubcc0\uacbd\uc5d0 \ub300\ud55c \uad6c\uccb4\uc801\uc778 \uc9c0\uce68\uc744 \ub9c8\ub828\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \uc9c0\uce68\uc740 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uac00 \uc774\ubbf8 \ucd9c\uc2dc\ub41c \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \ubcc0\uacbd\ud560 \ub54c \ub530\ub77c\uc57c \ud558\ub294 \ud504\ub85c\uc138\uc2a4\ub97c \uac04\ub7b5\ud558\uac8c \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc801\uadf9\uc801\uc778 \ud0dc\ub3c4\ub85c \uace0\uac1d\uc758 \uc774\uc775\uc5d0 \ucd08\uc810\uc744 \ub9de\ucd94\uace0 \uace0\uac1d\uc758 \uc694\uad6c\ub97c \ucda9\uc871\uc2dc\ud0a4\uae30 \uc704\ud574 \uc9c0\uc18d\uc801\uc73c\ub85c \uc81c\ud488\uc744 \uac1c\uc120\ud558\uba70 \uc548\uc804, \uc2e0\ub8b0\uc131, \ud658\uacbd \ubcf4\ud638 \uc694\uad6c \uc0ac\ud56d \ubc0f \ud601\uc2e0\uc5d0 \ub354\uc6b1\uc8fc\uc758\ub97c \uae30\uc6b8\uc785\ub2c8\ub2e4. \uce68\ud22c\uc131 \ud14c\uc2a4\ud130<\/a>,\ubc14\ub298 \uad00\ud1b5 \ud14c\uc2a4\ud2b8 \ubc29\ubc95<\/a>,\uc758\ub8cc \uc81c\ud488 \ud14c\uc2a4\ud2b8 \uae30\uae30 \uc81c\uc870\uc5c5\uccb4<\/a>,\uc758\ub8cc \uae30\uae30 \ud14c\uc2a4\ud130<\/a>,\uc778\uc7a5 \uc2dc\ud5d8\uae30 \uc81c\uc870\uc5c5\uccb4<\/a>,\uc218\ub3d9 \ud0c4\uc0b0 \ud14c\uc2a4\ud130<\/a>,CO2 \uccb4\uc801 \ud14c\uc2a4\ud130<\/a>,\uc758\ub8cc\uc6a9 \ubc14\ub298 \ucc9c\uc790 \ud14c\uc2a4\ud130<\/a>,\uc6a9\uc735 \ud750\ub984 \uc9c0\uc218 \ud14c\uc2a4\ud130 \uac00\uaca9<\/a>,\uc218\ud3c9 \uc778\uc7a5 \uc2dc\ud5d8\uae30 \uacf5\uae09\uc5c5\uccb4<\/a>,\uc804\ub3d9 \ucea1 \ud1a0\ud06c \ud14c\uc2a4\ud130<\/a>,\ud1a0\ud06c \ud14c\uc2a4\ud2b8 \uae30\uacc4<\/a><\/p>","protected":false},"excerpt":{"rendered":"

Medical Device Function and Performance Testing Meeting regulatory requirements in the varied world of medical devices requires deft project management. This can be a difficult and complex job. You have to balance the needs of a lot of different parties whilst staying within budget and holding to tight deadlines. The clinical needs and safety of […]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1124","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/posts\/1124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/comments?post=1124"}],"version-history":[{"count":0,"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/posts\/1124\/revisions"}],"wp:attachment":[{"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/media?parent=1124"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/categories?post=1124"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/test.geo-tester.com\/ko\/wp-json\/wp\/v2\/tags?post=1124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}